MAUDE Adverse Event Report: CLARIANCE SAS. ERISMA LP; SCREWDRIVER

Model Number 18710024

Device Problem Device Issue (2379)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Although the company has determined that the subject event in this mdr is likely not reportable, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21 cfr part 803 visual examination at the macroscopic level revealed that the fracture was located at the distal tip of the screwdriver shaft.The fractured tip was not provided for analysis.The fracture analysis report suggests that the driver underwent a quasi-static overload torsional shear failure starting at the hex lobes and extending to the others hex lobes of the shaft, the potential fracture termination site.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The root cause for the distal tip breaking cannot be positively determined.However, the fracture analysis report suggests that the driver underwent a quasi-static overload torsional shear failure starting at the hex lobes and extending to the others hex lobes of the shaft, the potential fracture termination site.As there has been no issue identified in the manufacturing or release of the device that could have customer and no systemic trends requiring immediate action have been observed.

Event Description

The distal tip of screwdriver broke off while inserting a polyaxial pedicle screw in the lumbar region of the spine.The broken tip has not been retrieved.It is captured in the screw inside of the patient.Surgery was completed with no further complications.

• Brand Name: ERISMA LP
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): CLARIANCE SAS.; 18 rue robespierre; beaurains, pas de calais 62217 ; FR 62217
• Manufacturer Contact: sylvain chambat ; 4001 n. ravenswood ave; suite 303-c; chicago, IL 60613 ; 7738687041
• MDR Report Key: 5917907
• MDR Text Key: 54346038
• Report Number: 3009962553-2016-00001
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 03700780623303
• UDI-Public: 03700780623303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18710024
• Device Catalogue Number: 18710024
• Device Lot Number: G160X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 109